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The Utility of Virtual Reality in the Management of Pediatric Functional Constipation With Pelvic Floor Dysfunction.

Primary Purpose

Functional Constipation, Pelvic Floor Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oculus go headset/virtual reality headset
Diaphragmatic breathing
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Constipation

Eligibility Criteria

7 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ages 7 to 21 years old
  • Meets Rome IV criteria for functional constipation and pelvic floor dysfunction
  • Developmentally appropriate to understand verbal instructions

Exclusion Criteria:

  • Co-existing medical conditions that include inflammatory bowel disease, Hirschsprung's Disease, cystic fibrosis, tethered cord, anal stenosis, sacral agenesis, spinal cord anomalies, untreated thyroid disease, untreated celiac disease, neurogenic bowel, cerebral palsy, major bowel surgery.
  • Non-English speaking

Sites / Locations

  • Stanford Hospital/Lucile Packard Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Virtual reality arm

Control

Arm Description

This arm will receive diaphragmatic breathing teaching by a medical professional and virtual reality module that teaches diaphragmatic breathing. This arm will be sent home with the virtual reality equipment and practice this breathing technique through the virtual reality module for 8 weeks.

This arm will receive diaphragmatic breathing teaching by a medical professional only. They will practice this breathing technique with a paper handout of diaphragmatic breathing technique instructions for 8 weeks.

Outcomes

Primary Outcome Measures

Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.
This outcome will assess cure of functional constipation and pelvic floor dysfunction.
Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.
This outcome will assess cure of functional constipation and pelvic floor dysfunction.
Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.
This outcome will assess cure of functional constipation and pelvic floor dysfunction.

Secondary Outcome Measures

Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module
Pediatric Quality of Life Inventory™ Gastrointestinal Symptoms Scales (PedsQL™ Gastrointestinal Symptoms Scales). Scale: 0-4. The total scale score is tallied from the sum of the reversed scores; the higher the score, the higher the health-related quality of life.
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module
Pediatric Quality of Life Inventory™ Gastrointestinal Symptoms Scales (PedsQL™ Gastrointestinal Symptoms Scales). Scale: 0-4. The total scale score is tallied from the sum of the reversed scores; the higher the score, the higher the health-related quality of life.
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module
Pediatric Quality of Life Inventory™ Gastrointestinal Symptoms Scales (PedsQL™ Gastrointestinal Symptoms Scales). Scale: 0-4. The total scale score is tallied from the sum of the reversed scores; the higher the score, the higher the health-related quality of life.
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire
Patient Assessment of Constipation Symptoms (PAC-SYM). The PAC-SYM (12-items) is a survey used to evaluate chronic constipation. Patients rank the symptoms on a 5 point Likert scale, ranging from 0 to 4, 0 being absent and 4 being very severe. For each symptom, score changes of 0.5 points indicate minimal improvement, and changes in 1 point correspond to moderate clinical improvement.
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire
Patient Assessment of Constipation Symptoms (PAC-SYM). The PAC-SYM (12-items) is a survey used to evaluate chronic constipation. Patients rank the symptoms on a 5 point Likert scale, ranging from 0 to 4, 0 being absent and 4 being very severe. For each symptom, score changes of 0.5 points indicate minimal improvement, and changes in 1 point correspond to moderate clinical improvement.
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire
Patient Assessment of Constipation Symptoms (PAC-SYM). The PAC-SYM (12-items) is a survey used to evaluate chronic constipation. Patients rank the symptoms on a 5 point Likert scale, ranging from 0 to 4, 0 being absent and 4 being very severe. For each symptom, score changes of 0.5 points indicate minimal improvement, and changes in 1 point correspond to moderate clinical improvement.

Full Information

First Posted
November 13, 2019
Last Updated
July 7, 2022
Sponsor
Stanford University
Collaborators
Lucile Packard Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04172948
Brief Title
The Utility of Virtual Reality in the Management of Pediatric Functional Constipation With Pelvic Floor Dysfunction.
Official Title
The Utility of Virtual Reality in the Management of Pediatric Functional Constipation With Pelvic Floor Dysfunction.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Lucile Packard Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine if the adjunctive use of a Virtual Reality (VR) module on diaphragmatic breathing (DB) can improve the quality of life (QOL) and symptoms of children with functional constipation (FC) with pelvic floor dysfunction (PFD) who are receiving standard of care treatment. To assess if a VR module on DB can decrease healthcare utilization for children with FC with PFD.
Detailed Description
The investigators will assess if the use a Virtual Reality (VR) module on diaphragmatic breathing (DB) can improve quality of life, constipation symptoms, and decrease healthcare utilization for children with functional constipation (FC) with pelvic floor dysfunction (PFD). FC is a common pediatric condition with a high prevalence and $4.25 billion yearly in healthcare expenditures. FC is often complicated with PFD as seen through stool withholding behaviors. Children with FC with PFD are referred to occupational therapy for biofeedback and DB training as standard of care. Occupational therapy uses to teach children with FC with PFD to relax their abdominal muscles, and subsequently their pelvic floor muscles, facilitating a more complete bowel evacuation. VR is a technology currently employed in rehabilitation services, anesthesiology and surgery. VR can provide a fun, immersive environment with a feedback component for children with FC to learn DB effectively and build a positive association with toileting. The purpose of this study is to examine if a virtual reality module that teaches children diaphragmatic breathing through an immersive game can improve the quality of life and decrease health care utilization for children with functional constipation and pelvic floor dysfunction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Constipation, Pelvic Floor Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Care Provider
Masking Description
Care provider will be blinded to the intervention.
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality arm
Arm Type
Experimental
Arm Description
This arm will receive diaphragmatic breathing teaching by a medical professional and virtual reality module that teaches diaphragmatic breathing. This arm will be sent home with the virtual reality equipment and practice this breathing technique through the virtual reality module for 8 weeks.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
This arm will receive diaphragmatic breathing teaching by a medical professional only. They will practice this breathing technique with a paper handout of diaphragmatic breathing technique instructions for 8 weeks.
Intervention Type
Device
Intervention Name(s)
Oculus go headset/virtual reality headset
Intervention Description
10 minute virtual reality tutorial on diaphragmatic breathing, a game in practicing diaphragmatic breathing, and two scenarios in which the patient can also practice diaphragmatic breathing.
Intervention Type
Behavioral
Intervention Name(s)
Diaphragmatic breathing
Intervention Description
10 minute tutorial on diaphragmatic breathing by a medical professional.
Primary Outcome Measure Information:
Title
Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.
Description
This outcome will assess cure of functional constipation and pelvic floor dysfunction.
Time Frame
Baseline, 1 visit between week 2
Title
Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.
Description
This outcome will assess cure of functional constipation and pelvic floor dysfunction.
Time Frame
Baseline, week 4
Title
Change in baseline in Rome criteria for functional constipation and symptoms of pelvic floor dysfunction.
Description
This outcome will assess cure of functional constipation and pelvic floor dysfunction.
Time Frame
Baseline, week 8
Secondary Outcome Measure Information:
Title
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module
Description
Pediatric Quality of Life Inventory™ Gastrointestinal Symptoms Scales (PedsQL™ Gastrointestinal Symptoms Scales). Scale: 0-4. The total scale score is tallied from the sum of the reversed scores; the higher the score, the higher the health-related quality of life.
Time Frame
Baseline, 1 visit between week 2
Title
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module
Description
Pediatric Quality of Life Inventory™ Gastrointestinal Symptoms Scales (PedsQL™ Gastrointestinal Symptoms Scales). Scale: 0-4. The total scale score is tallied from the sum of the reversed scores; the higher the score, the higher the health-related quality of life.
Time Frame
Baseline, week 4
Title
Change from baseline in Pediatric Quality of Life (QOL) gastrointestinal (GI) module
Description
Pediatric Quality of Life Inventory™ Gastrointestinal Symptoms Scales (PedsQL™ Gastrointestinal Symptoms Scales). Scale: 0-4. The total scale score is tallied from the sum of the reversed scores; the higher the score, the higher the health-related quality of life.
Time Frame
Baseline, week 8
Title
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire
Description
Patient Assessment of Constipation Symptoms (PAC-SYM). The PAC-SYM (12-items) is a survey used to evaluate chronic constipation. Patients rank the symptoms on a 5 point Likert scale, ranging from 0 to 4, 0 being absent and 4 being very severe. For each symptom, score changes of 0.5 points indicate minimal improvement, and changes in 1 point correspond to moderate clinical improvement.
Time Frame
Baseline, 1 visit between week 2
Title
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire
Description
Patient Assessment of Constipation Symptoms (PAC-SYM). The PAC-SYM (12-items) is a survey used to evaluate chronic constipation. Patients rank the symptoms on a 5 point Likert scale, ranging from 0 to 4, 0 being absent and 4 being very severe. For each symptom, score changes of 0.5 points indicate minimal improvement, and changes in 1 point correspond to moderate clinical improvement.
Time Frame
Baseline, week 4
Title
Change from baseline in Patient Assessment of Constipation Symptoms (PAC-SYM) constipation questionnaire
Description
Patient Assessment of Constipation Symptoms (PAC-SYM). The PAC-SYM (12-items) is a survey used to evaluate chronic constipation. Patients rank the symptoms on a 5 point Likert scale, ranging from 0 to 4, 0 being absent and 4 being very severe. For each symptom, score changes of 0.5 points indicate minimal improvement, and changes in 1 point correspond to moderate clinical improvement.
Time Frame
Baseline, week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 7 to 21 years old Meets Rome IV criteria for functional constipation and pelvic floor dysfunction Developmentally appropriate to understand verbal instructions Exclusion Criteria: Co-existing medical conditions that include inflammatory bowel disease, Hirschsprung's Disease, cystic fibrosis, tethered cord, anal stenosis, sacral agenesis, spinal cord anomalies, untreated thyroid disease, untreated celiac disease, neurogenic bowel, cerebral palsy, major bowel surgery. Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Ming Yeh, MD
Organizational Affiliation
Stanford Hospital/Lucile Packard Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alice C Huang, MD
Organizational Affiliation
Stanford Hospital/Lucile Packard Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Hospital/Lucile Packard Children's Hospital
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Utility of Virtual Reality in the Management of Pediatric Functional Constipation With Pelvic Floor Dysfunction.

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